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NCT07684235PHASE3Recruiting

Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)

Amgen

Start Date

7/23/2026

Completion Date

3/19/2028

Summary

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).

Eligibility Criteria

Age Range: 18 years to 99 years

Inclusion Criteria: * Signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Completed the parent trial (2010181) * Completed week 72 visit in parent trial * Did not permanently discontinue trial intervention in parent trial * Randomized within 7 Days of week 72 visit in the parent trial * Participants must use protocol-specified contraception during treatment, and for an additional 16 weeks after the last dose of trial intervention Exclusion Criteria: * Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity * Body mass index ≤ 18.5 kilograms per meter square (kg/m\^2) * Participant has known sensitivity to any of the products or components to be administered during dosing * History of ischemic optic neuropathy * Any malignancy diagnosed during parent trial (20210181) except for the following treated with curative intent: nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ. * Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative\[s\]) history of medullary thyroid cancer. * Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at week 72 visit from parent trial before randomization * Any suicidal ideation of category 4 or 5 OR any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit version at week 72 visit from parent trial before randomization. * Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator. * History or evidence of any other clinically significant disorder, condition, or disease (including, but not limited to known drug or alcohol abuse, eating disorders, and conditions identified during the parent trial) that, in the opinion of the investigator, would pose a risk to participant safety. * Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or * Planning to become pregnant or breastfeed while on trial until an additional 16 weeks after the last dose of trial intervention. * Major surgical procedures planned during the trial. * Participants with minor surgical procedures (not requiring general anesthesia or deep sedation) planned during the trial may be eligible at the discretion of the investigator. * Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).

Interventions

DRUG

Maridebart cafraglutide

DRUG

Placebo

Interested in This Trial?

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Conditions

ObesityOverweight

Locations

Pinnacle Research Group LLC

Anniston, Alabama 36207

United States

Alliance For Multispecialty Research - Daphne

Daphne, Alabama 36526

United States

Alliance for Multispecialty Research Mobile

Mobile, Alabama 36608

United States

Ark Clinical Research- Tustin

Fountain Valley, California 92708

United States

Long Beach Clinical Trials Services Inc

Long Beach, California 90806

United States

Ark Clinical Research- Long Beach

Long Beach, California 90815

United States

Catalina Research Institute

Montclair, California 91763

United States

Artemis Institute for Clinical Research

Riverside, California 92503

United States

Artemis Institute for Clinical Research

San Diego, California 92103

United States

Apex Clinical Research

San Diego, California 92120

United States

Southern California Clinical Research

Santa Ana, California 92701

United States

Diablo Clinical Research

Walnut Creek, California 94598

United States

Chase Medical Research LLC

Waterbury, Connecticut 06708

United States

Jacksonville Center for Clinical Research

Jacksonville, Florida 32216

United States

Clinical Neuroscience Solutions - Jacksonville

Jacksonville, Florida 32256

United States

South Florida Wellness and Clinical Research Institute

Lauderhill, Florida 33351

United States

Optimus U Corporation

Miami, Florida 33135

United States

Research Institute of South Florida

Miami, Florida 33173

United States

Indago Research and Health Center

Miami Lakes, Florida 33016

United States

Renstar Medical Research

Ocala, Florida 34470

United States

Clinical Neuroscience Solutions - Orlando

Orlando, Florida 32801

United States

Combined Research Orlando Phase I IV

Orlando, Florida 32807

United States

Florida Institute for Clinical Research

Orlando, Florida 32825

United States

Encore Medical Research of Weston LLC

Weston, Florida 33331

United States

Center for Advanced Research and Education

Gainesville, Georgia 30501

United States

Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group

Union City, Georgia 30291

United States

East-West Medical Research

Honolulu, Hawaii 96814

United States

Solaris Clinical Research

Meridian, Idaho 83646

United States

Flourish Research - Great Lakes Clinical Trials

Chicago, Illinois 60640

United States

Endeavor Health

Skokie, Illinois 60077

United States

Evanston Premier Healthcare Research LLC

Skokie, Illinois 60077

United States

JCCT- Juno Northwest Houston

Lenexa, Kansas 66219

United States

Alliance for Multispecialty Research Newton

Newton, Kansas 67114

United States

Louisville Metabolic and Atherosclerosis Research Center

Louisville, Kentucky 40213

United States

Velocity Clinical Research - Baton Rouge

Baton Rouge, Louisiana 70809

United States

Tandem Clinical Research - Marrero

Marrero, Louisiana 70072

United States

Headlands Research - Detroit

Southfield, Michigan 48034

United States

Prime Health and Wellness Sky Clinical Research Network Group

Fayette, Mississippi 39069

United States

Alliance for Multispecialty Research - Kansas City

Kansas City, Missouri 64114

United States

Vector Clinical Trials

Las Vegas, Nevada 89128

United States

Palm Research Center Inc

Las Vegas, Nevada 89148

United States

Velocity Clinical Research- Binghamton

Binghamton, New York 13905

United States

Rochester Clinical Research

Rochester, New York 14609

United States

Accellacare of Hickory

Hickory, North Carolina 28602

United States

Carolina Research Center Inc

Shelby, North Carolina 28150

United States

Clinical Trial Investigator Clinical Research Center

Cincinnati, Ohio 45212

United States

Velocity Clinical Research - Cincinnati

Cincinnati, Ohio 45219

United States

Alliance for Multispecialty Research - Norman

Norman, Oklahoma 73069

United States

Capital Area Research LLC

Newport, Pennsylvania 17074

United States

Velocity Clinical Research - Providence

East Greenwich, Rhode Island 02818

United States

Tribe Clinical Research LLC Dba Mountain View Clinical Research

Greenville, South Carolina 29607

United States

New Phase Research and Development

Knoxville, Tennessee 37909

United States

Accellacare US Inc., d/b/a Accellacare of Knoxville

Knoxville, Tennessee 37938

United States

Elligo Clinical Research Center

Austin, Texas 78704

United States

Johnson County Clinical Trials Juno Bellaire

Bellaire, Texas 77401

United States

Cedar Health Research, LLC

Dallas, Texas 75235

United States

Cedar Health Research, LLC

Dallas, Texas 75251

United States

Epic Medical Research - Red Oak

DeSoto, Texas 75115

United States

Great Lakes Research Institute El Paso Research

El Paso, Texas 79905

United States

Biopharma Informatic, LLC

Houston, Texas 77043

United States

Southern Endocrinology Associates PA

Mesquite, Texas 75149

United States

Great Lakes Research Institute - McAllen Research

Pharr, Texas 78557

United States

Clinical Trials of Texas

San Antonio, Texas 78229

United States

Sugar Lakes Family Practice

Sugar Land, Texas 77479

United States

Pantheon Clinical Research

Bountiful, Utah 84010

United States

Alliance for Multispecialty Research Layton Research Center

Layton, Utah 84041

United States

Chrysalis Clinical Research, LLC

St. George, Utah 84790

United States

Washington Center for Weight Management and Research, Inc

Arlington, Virginia 22206

United States

Health Research of Hampton Roads

Newport News, Virginia 23606

United States

Selma Medical Associates

Winchester, Virginia 22601

United States

Allegiance Research Specialists

Wauwatosa, Wisconsin 53226

United States

Emeritus Research Sydney

Botany, New South Wales 2019

Australia

Novatrials

Charlestown, New South Wales 2290

Australia

Canopy Clinical Sutherland

Miranda, New South Wales 2228

Australia

Canopy Clinical Wollongong

Miranda, New South Wales 2228

Australia

Logan Hospital

Meadowbrook, Queensland 4131

Australia

Fusion Clinical Research

Adelaide, SAU 5000

Australia

Emeritus Research Camberwell

Camberwell, Victoria 3124

Australia

Canopy Clinical Altona North

North Altona, Victoria 3025

Australia

Wharton Medical Clinic

Hamilton, Ontario L8L 5G8

Canada

Curans Heart Center

Thunder Bay, Ontario P7B 6V4

Canada

Ecogene-21

Chicoutimi, Quebec G7H 7K9

Canada

Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic

Yokohama, Kanagawa 231-0023

Japan

Doujin Memorial Foundation, Meiwa Hospital

Chiyoda-ku, Tokyo 101-0041

Japan

Tokyo Asbo Clinic

Chuo-ku, Tokyo 104-0031

Japan

Medical Corp Seikoukai New Medical Research System Clinic

Hachioji-shi, Tokyo 192-0046

Japan

Medical Corporation AOT Shinagawa Strings Clinic

Minato-ku, Tokyo 108-0075

Japan

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo 160-0004

Japan

Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic

Suginami-ku, Tokyo 166-0003

Japan

Ponce Medical School Foundation Inc

Ponce, 00716

Puerto Rico

Puerto Rico Medical Research Inc.

Ponce, 00717

Puerto Rico

Latin Clinical Trial Center

San Juan, 00909

Puerto Rico